Project & Program Management
We provide experienced project and program management leadership to help medical device companies deliver complex initiatives on time, within budget, and in full compliance with regulatory requirements. From single-product launches to enterprisewide quality system transformations, we bring structure, accountability, and deep industry expertise to every engagement.
Project & Program Management
- New Product Development (NPD) Program Management — We lead cross-functional teams through the full product development lifecycle, managing design controls, stage gate planning, regulatory timelines, and reporting from concept through commercialization.
- Regulatory Submission Project Management — We coordinate and manage the preparation of FDA submissions (510(k), PMA, De Novo) and CE marking technical files, keeping teams aligned and submissions on schedule.
- Quality System Implementation & Remediation — We manage the planning, execution, and closure of quality system implementation or remediation projects, ensuring all deliverables are completed, documented, and audit-ready.
- Cross-Functional Team Leadership — We facilitate alignment across engineering, quality, regulatory, operations, and clinical teams, driving clear ownership, decision-making, and communication throughout the project.
- Schedule & Risk Management — We develop and maintain project schedules, identify risks early, and implement mitigation strategies to protect timelines and minimize downstream impacts on product launch or approval.
- Program Governance & Reporting — We establish governance frameworks, KPIs, and executive reporting cadences that give leadership real-time visibility into program health, milestones, and critical issues.
- Vendor & Contract Management — We manage relationships with CROs, CMOs, consultants, and other third-party partners to ensure deliverables are met and standards are maintained throughout the supply and development chain.
Staff Augmentation & Delivery Model
- IT Staff Augmentation & Process Engineering — We offer best-in-class IT Staff Augmentation and Process Engineering for companies large and small, whether they need a single resource or a full team. We maintain a comprehensive database of pre-qualified candidates with varied specializations and sector experience.
- Flexible Engagement Models — We offer flexible budget and project-specific placement models, including staff augmentation, T&M, and SOW-based team services, to help you quickly develop your team to meet your business and company goals.
- Global Recruiting & Remote Teams — Our global recruiting model can help you build dedicated teams that work together remotely from anywhere in the world. Our retention rates are second to none, and our domain- and skill-specific approach is tailored to meet each client's unique needs.
IT Consulting & System Upgrades
- Technology Strategy Advisory — We provide advisory services that help clients assess different technology strategies and, in doing so, align their technology strategies with their business or process strategies.
- Modern Delivery Practices — We help build a culture, a set of operating principles, and practices that enable application development teams to deliver code changes more frequently and reliably.
- Quality & Engineering Support — We support quality assurance and quality control needs across program workstreams, helping ensure deliverables meet both technical specifications and regulatory expectations.
Why It Matters
Medical device development is uniquely challenging: regulatory complexity, design control requirements, and cross-functional dependencies create significant project risk. Without experienced program management, timelines slip, costs escalate, and compliance gaps emerge. Our leadership keeps your projects moving forward with the rigor and discipline the industry demands, backed by a flexible delivery model that scales from a single specialist to a full dedicated team.
Who We Serve
We partner with medical device startups, growing manufacturers, and established companies that need experienced program leadership and skilled talent, whether as a fractional resource, interim support, dedicated project management for a critical initiative, or a fully staffed delivery team.
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